Randomized Adaptive Bioequivalence Study of Rifaximin 200 mg Tablets in Healthy Subjects Under Fed Conditions

The primary objective is to evaluate the bioequivalence of single oral doses of rifaximin 200 mg film-coated tablets from Antibiotice SA and Normix® 200 mg film-coated tablets from Alfasigma S.P.A. under fed conditions in healthy subjects. This is clinically relevant for confirming comparable systemic exposure between the two formulations. No secondary objectives are specified.

The study population consisted of healthy volunteers of both sexes, including females and males, with an age range corresponding to code 3. The total number of participants was not provided by the sponsor. The available information indicates that the trial population was selected from healthy subjects. No additional details were provided regarding general health status, lifestyle considerations, or specific inclusion or exclusion criteria.

The study is a randomized, balanced, two-treatment, two-sequence, single oral dose, two-stage crossover adaptive bioequivalence trial conducted in healthy subjects under fed conditions. The design includes two treatment periods, with participants assigned to receive the test and reference products in alternate sequences. The overall trial duration is estimated from May 2026 to September 2026. The study plan includes an inclusion screening visit to assess eligibility, followed by the dosing periods and scheduled follow-up assessments to collect safety and pharmacokinetic data. An end-of-study visit is performed after completion of all required trial procedures. Participant involvement is expected to last for the full duration of the individual study schedule, including screening, treatment periods, follow-up, and the end-of-study assessment. Early termination may occur if eligibility criteria are no longer met, if a participant withdraws consent, or if discontinuation is required for safety or protocol-related reasons.

No investigational or comparator treatments were specified in the source data for this clinical trial.

Efficacy will be assessed in healthy subjects using the parameters and methods specified in the clinical trial protocol.